Associate Director, Quality Risk Specialist
Bristol Myers Squibb
4 months ago
Remote friendly (Madison, NJ)
United States
Operations
Associate Director, RBQM - HOCT, ICN
Key Responsibilities
- Develop the Quality Narrative (or equivalent) at study/ASSET/TA level to document end-to-end risk-based quality management for CtQ data, processes, and vendors (risk/issue management).
- Partner with Drug Development during protocol authoring to embed Quality by Design and identify CtQ data/processes/vendors with appropriate risk mitigations.
- During trial conduct, provide feedback on CtQ risks; adjust mitigation strategies when new/unanticipated issues arise (partner with CAPA CoE, Serious Breach, and Clinical Quality Assurance; use audits/inspections/internal events/significant issues/external intelligence).
- Conduct study-level quality assurance spot checks.
- Assist in defining Acceptable Ranges/QTL and KRIs for CtQ data.
- Support cause/critical/complex quality issues and serious breaches for the TA as needed.
- Provide quality/compliance consultation to clinical trials teams; monitor/evaluate CtQ factors and adapt quality plans.
- Provide regulatory intelligence; ensure compliance with ICH (E8, E6, E9) and other relevant requirements.
- Escalate/communicate quality issues (including potential misconduct/significant deviations) to business and Health Authorities; provide R&D quality expertise, training, and best practices.
Qualifications
- B.S. and/or M.S. in Chemistry, Biology, Health, or Quality (or equivalent).
- 8+ years QA or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance.
Required Competencies/Skills
- ICH/GCP, regulatory guidelines, clinical research and Quality Assurance knowledge.
- Strong Risk-Based Quality Management and applied risk management (assessment/analysis/evaluation/reporting/communication/treatment/continuous review).
- HOCT/ICN therapeutic area understanding; regulatory inspection experience.
- Analytical, conceptual/data proficiency, problem-solving, professional communication, and project management.
Key Responsibilities
- Develop the Quality Narrative (or equivalent) at study/ASSET/TA level to document end-to-end risk-based quality management for CtQ data, processes, and vendors (risk/issue management).
- Partner with Drug Development during protocol authoring to embed Quality by Design and identify CtQ data/processes/vendors with appropriate risk mitigations.
- During trial conduct, provide feedback on CtQ risks; adjust mitigation strategies when new/unanticipated issues arise (partner with CAPA CoE, Serious Breach, and Clinical Quality Assurance; use audits/inspections/internal events/significant issues/external intelligence).
- Conduct study-level quality assurance spot checks.
- Assist in defining Acceptable Ranges/QTL and KRIs for CtQ data.
- Support cause/critical/complex quality issues and serious breaches for the TA as needed.
- Provide quality/compliance consultation to clinical trials teams; monitor/evaluate CtQ factors and adapt quality plans.
- Provide regulatory intelligence; ensure compliance with ICH (E8, E6, E9) and other relevant requirements.
- Escalate/communicate quality issues (including potential misconduct/significant deviations) to business and Health Authorities; provide R&D quality expertise, training, and best practices.
Qualifications
- B.S. and/or M.S. in Chemistry, Biology, Health, or Quality (or equivalent).
- 8+ years QA or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance.
Required Competencies/Skills
- ICH/GCP, regulatory guidelines, clinical research and Quality Assurance knowledge.
- Strong Risk-Based Quality Management and applied risk management (assessment/analysis/evaluation/reporting/communication/treatment/continuous review).
- HOCT/ICN therapeutic area understanding; regulatory inspection experience.
- Analytical, conceptual/data proficiency, problem-solving, professional communication, and project management.